Kornimate/medical-research-clean huggingface dataset:
refining the target for deep brain stimulation (dbs) in severe, treatment refractory obsessive compulsive disorder (ocd)

Conditions: Obsessive-Compulsive Disorder

Summary: in select, therapy resistent patients with obsessive compulsive disorder (ocd) deep brain stimulation (dbs) has been used as a treatment. dbs is a therapy modality in which electrodes are implanted within specific sub-structures of the brain in order to modulate the activity in targeted neural circuits associated with different neurological disorders. the results of this novel approach to psychiatric disorders have been optimistic. this study aims to investigate wether or not the distance to target location has an influence on the outcome. in order to deliver dbs, leads containing four electrodes are implanted into the brain target in the ventral capsule/ventral striatum (vc/vs). after an optimization period, patients enter a triple blind randomised two fazed crossover design of two periods of three months. in both crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the stimulation conditions. these conditions are stimulation on (at optimal parameters) and stimulation off. stimulation parameters are constant during the entire period. during the second crossover branch, stimulation conditions are reversed for all patients.


Eligibility criteria:
inclusion criteria: * diagnosis of ocd following the diagnostic and statistical manual of mental disorders-fourth edition (dsm-iv) criteria for ocd (300.3). * failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for ocd. * failure of documented trial of cognitive and behavioural therapy * duration of illness: min. 5 year * y-bocs at least 30/40. * age: 20-65 year exclusion criteria: * dsm-iv diagnosis on axis 2 of severe personality disorder in cluster a or b, especially in the case of heightened risk for acting-out behavior. * dsm-iv diagnosis on axis 3 of organic brain pathology or significant abnormalities on mri. * present or past history of psychotic symptoms. * present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months). * any disorder affecting cognitive functioning, other than motor tics and gilles de la tourette's syndrome * mental retardation. a minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze. * the patient must be juridical free.

Keywords: obsessive-compulsive disorder deep brain stimulation psychosurgery
early-life mri biomarkers of longer-term respiratory morbidity in infants born extremely preterm (emblem)

Conditions: Lung Function; BPD - Bronchopulmonary Dysplasia

Summary: bronchopulmonary dysplasia (bpd) is a common, major complication of premature birth, associated with developmental and health consequences that continue into adulthood. prediction of who will have these problems is challenging using traditional definitions of disease. it is believed that underdevelopment and injury occur in both lung tissue and the blood vessels in the lungs, with a sophisticated interplay between them that contributes to lung disease seen in prematurity. new magnetic resonance imaging (mri) techniques can delineate tissue structure with unprecedented granularity, assessing lung tissue, blood vessels, and their interplay. the ability to identify, at an early stage, those infants destined for chronic lung disease with greater certainty will be useful in counseling families and critical for the effective introduction of promising new bpd therapies. 319 infants born less than 29 weeks gestation will be recruited from 4 centres, including 5 babies who received stem cell therapy in a clinical trial. babies will be evaluated at 36 weeks post-conception with lung mri, oscillometry (lung function), echocardiogram (heart ultrasound), and oscillometry. lung health will be assessed every 3 months by phone questionnaire and chart review. at 18-21 months post-conception, babies will undergo neurodevelopmental assessment and lung function testing. the investigators will look at how well baseline mri markers predict subsequent lung health and development, independently and combined with echocardiogram, lung ultrasound, and traditional markers of bpd. the investigators anticipate that these new mri markers will measure lung health safely and longitudinally in babies born extremely preterm. by identifying predictors of longer-term lung disease, clinicians will be able to allocate resources to babies at the highest risk of severe disease. further, the investigators envision that mri will help identify babies who would benefit most from interventions like stem cell therapy and be useful for evaluation of future treatments.


Eligibility criteria:
inclusion criteria: 1. infants born at \<29 weeks gestation; 2. currently \<36 weeks pma. exclusion criteria: 1. known interstitial lung disease, congenital lung anomaly, ciliary dysfunction, immunodeficiency, cystic fibrosis, neuromuscular disease, or structural heart disease (other than atrial septal defect/hemodynamically insignificant ventricular septal defect/patent ductus arteriosus); 2. genetic syndrome or congenital anomaly; 3. contraindications for mri or transport; 4. invasive or non-invasive ventilation that cannot be safely removed for mri; 5. current respiratory infection; 6. family cannot speak english/french; 7. transferred to another hospital prior to baseline study visit 8. not receiving follow-up at one of the study centres.
study to evaluate the efficacy of botulinum toxin serotype a injections for cervicobrachial myofascial syndrome

Conditions: Cervicobrachial Neuralgia; Myofascial Pain Syndromes

Summary: several studies have previously examined the use of botulinum toxin serotype a for myofascial pain of the neck and shoulders (cervicobrachial syndrome). these studies have suffered from: 1. inclusion of confounding conditions in the proband group, and 2. inability to identify predictors of response. this study attempts to define the characteristics of responders to botulinum serotype a for myofascial pain of the neck and shoulders (cervicobrachial syndrome).

design: single-center, double-blind, placebo-controlled, enriched trial. subjects will wash-out of their existing pain medications at least 2 weeks prior to baseline visit. at baseline, patients with a numerical pain rating of 4 or greater will be injected with botulinum toxin serotype a. at 14 weeks postinjection, those who at the 6 weeks post-injection visit had at least a 50% decrease in their pain outcome measures will be randomized into one of two treatment groups. group 1 will receive a second btx injection while group 2 will receive an injection of saline and both groups will be followed for an additional 6 weeks.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18-65 years. 2. patients present with bilateral posterior neck/cervical muscle pain for greater than 8 weeks 3. patients have numerical pain rating of 4 or greater 4. patients willing to adhere to a physical therapy program of 2-3 visits for myofascial release and also home stretching exercises for the length of the study 5. subjects willing to discontinue all pain medications except ibuprofen and a non-opioid rescue medication for the duration of the study. 6. women of child-bearing potential must be using a reliable means of contraception and have a negative urine pregnancy test prior to injection of botox. exclusion criteria: 1. subjects currently taking schedule ii narcotics 2. no new non-pain medications or change in non-pain medications within 2 months of screening or throughout the study 3. pregnant or breastfeeding women 4. use of investigational drugs within one month of study 5. involvement in litigation surrounding neck pain 6. significant medical or psychiatric disease 7. patients with clinical depression (beck's depression score) 8. alcohol or drug abuse, in the opinion of the investigator

Keywords: botulinum toxin serotype a cervicobrachial syndrome myofascial pain cervicothoracic myofascial pain propulsion postural abnormality
treatment of medial epicondyle fractures in children and adolescents

Conditions: Medial Epicondyle Fracture of the Humerus; 7 To16 Year Old Children and Adolecents; More Than 2 Mm of Displacement

Summary: cast immobilization in situ versus open reduction and internal fixation of displaced medial epicondyle fractures in children between 7 and 16 years old. a non-inferiority randomized controlled trial.

this is a multicenter, controlled, prospective, randomized non-inferiority study comparing operative treatment to non-operative treatment of over 3 mm dislocated pediatric medial epicondyle fractures without joint incarceration or ulnar nerve dysfunction. a total of 120 patients will be randomized in 1:1 ratio to either operative or non-operative treatment. the study will have a parallel non-randomized patient preference arm. non-operative treatment will be upper limb immobilization with long arm cast for 4 weeks. operative treatment will be open reduction and internal fixation (orif). data is collected at baseline and at each follow-up up to 2 years. quick-dash is used as primary outcome measure. secondary outcomes are patient reported pain, differences in range of motion, pedsql life inventory questionnaire as well as mayo elbow preformance score.

Eligibility criteria:
inclusion criteria: - over 2 mm displaced medial epicondyle fracture of humerus on primary ap or lateral x-ray exclusion criteria: * ulnar nerve dysfunction * pathological fracture * open fracture * systemic bone disease * concomitant fracture or injury of the same upper limb requiring operative intervention * other disease preventing participation in full follow-up regime or range of motion exercises
mindfulness-based cognitive therapy for patients with functional disorders

Conditions: Somatization Disorder; Functional Disorders; Bodily Distress Disorder

Summary: the aim of the study is to examine the efficacy of mindfulness-based cognitive therapy (mbct) in patients with functional disorders defined as severe bodily distress disorder. hypothesis: mbct can ameliorate the symptoms of fd defined as severe bodily distress disorder and decrease health care utilization beyond the effect of shared care. patients treated with mbct will function better physically and socially than patients treated with shared care at 12 months' follow-up.

functional disorders (fd) are conditions where patients complain of multiple medically unexplained physical symptoms. fd defy the clinical picture of any conventionally defined disease and cannot adequately be supported by clinical or para-clinical findings. the disorders are common in all medical settings, both in primary and secondary care. the conditions range from mild to severe and disabling, they are costly for society due to the patients' high health care use, and the patients' social and functional level is reduced. there is no well-established, effective pharmacological, or psychotherapeutical treatment offer today. in randomized controlled trials, cognitive behavioural treatment has shown to be effective for selected patient groups suffering from fd. however, only a few trials have been made, especially concerning treatment of the most severe disorders. randomized controlled trials on mindfulness-based stress reduction (mbsr) have shown mitigation of stress, anxiety, and dysphoria in a general population sample and reduction in total mood disturbances and stress symptoms in a medical population sample. furthermore, rcts in mindfulness-based cognitive therapy (mbct) have demonstrated a 50 % reduction of depression relapse for individuals, who have experienced three or more previous episodes. we wish to examine the efficacy of mbct in patients with functional disorders defined as severe bodily distress disorder.

Eligibility criteria:
inclusion criteria: * functional disorder defined as bodily distress disorder, severe * moderate to severe impairment * the disorder's functional component can easily be separated from a coexisting well-defined physical disease * no lifetime-diagnosis of psychosis, bipolar affective disorder, or depression with psychotic symptoms * age 20-50 years * patients of scandinavian origin, who understand, read, write, and speak danish exclusion criteria: * no informed consent * an acute psychiatric disorder demanding other treatment, or if the patient is suicidal * abuse of narcotics or alcohol or (non-prescribed) medicine * pregnancy

Keywords: mindfulness-based cognitive therapy somatization disorder medically unexplained symptoms functional somatic symptoms sf-36
steps implementation trial

Conditions: Autism Spectrum Disorder

Summary: this study will inform understanding of how to support emerging adults with autism spectrum disorder (asd). the investigators will use a theoretically informed and research-based transition support program developed for people with asd and test how effective it is when delivered by community agencies. results will provide information on the effectiveness of the program as well as on mechanisms of change and contextual factors that promote or impede implementation.

the long-term goal of this research is to improve adult outcomes for people with autism spectrum disorder (asd). autistic adolescents and young adults tend to have worse outcomes with respect to employment, education, and quality of life, than neurotypical peers. these outcomes include under-enrollment into college, unemployment, and limited functional independence. research-informed transition planning that addresses core impairments in skills related to adult autonomy, including self-knowledge, self-determination, and self-regulation, may improve outcomes for this growing population. in prior research, investigators developed a stakeholder involved transition program (steps) and found it to be feasible, acceptable, and efficacious. data from a small randomized controlled trial (rct) focusing on feasibility indicated that it was acceptable to participants and suggested steps was effective in improving readiness for transition to adulthood. the team will now test the effectiveness of steps, and engagement of target mechanisms, in partnership with four community agencies. this study is designed as a hybrid type 1, which focuses primarily on intervention effectiveness with a secondary focus on factors related to implementation. immediate (post-treatment) and longer-term (six month follow-up) clinical outcomes of adult functional outcomes and vocational engagement will be assessed. the degree to which steps leads to change in the theoretical mediating mechanisms (i.e., adult autonomy skills) will be examined, as well as a formal test of mediation (i.e., the degree to which change in adult autonomy skills leads to change in adult functional outcomes). providers will provide qualitative information on implementation such as thoughts on steps' cultural sensitivity, and quantitative data on the appropriateness, feasibility, and acceptability of steps. providers' sustained use of steps with clients in the six months after study enrollment has ended will also be tracked. this research will produce findings that have the potential to shift clinical practice related to transition to adulthood for people with asd. in light of the fact that approximately 70,000 people with asd age into adulthood every year and the economic burden associated with asd, the potential public health impact of this research is considerable.

Eligibility criteria:
inclusion criteria: * 16-25 years of age * have confirmed diagnosis of asd * want to participate in steps * have a caregiver/parent who can complete assessments exclusion criteria: * presence of suicidal/homicidal intent

Keywords: transition adulthood employment education
anastomotic techniques in pancreaticoduodenectomy

Conditions: Pancreatic Cancer; Pancreatic Fistula

Summary: there are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. this can be performed either to the jejunum or to the stomach. the aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected. previous papers have shown similar results in both groups although non randomized data suggested that the pancreaticogastrostomy (drainage into the stomach) may be superior


Eligibility criteria:
inclusion criteria: 1. pancreaticoduodenectomy for adenocarcinoma of the pancreatic head 2. resectable tumour exclusion criteria: 1. chronic pancreatitis/benign tumours- 2. tumours extending into the body of the pancreas 3. tumours with metastasis beyond regional lymph nodes 4. requirement for sub total pancreatectomy 5. prolonged hypotension - \< 80 mm of hg for more than 30 min

Keywords: pancreatic anastomosis whipple operation
management of digestive haemorrhaging in chru of brest during 2009 and 2014

Conditions: Gastro Intestinal Bleeding

Summary: gastro intestinal (gi) bleeding is relatively frequent and may lead to intensive care unit admission. although a restrictive strategy for red blood cell transfusion is supported by a large randomized controlled trial literature, less is known about the impact of transfusion strategy of other blood components and administration of anti fibrinolytic on clinical outcomes. this study aims to identify parameters that may be associated with the risk of further bleeding in patients admitted to icu for gi bleeding.


Eligibility criteria:
inclusion criteria: * patients with gastro intestinal bleeding admitted to either medical or surgical intensive care unit exclusion criteria: * patients retrieved from another hospital * age \< 18 years consent withdrawal

Keywords: gastro intestinal bleeding; transfusion, outcomes
development of a keratoconus detection algorithm by deep learning analysis and its validation on eyestar images

Conditions: Keratoconus; Eye Diseases; Cataract; Corneal Ectasia

Summary: monocentric clinical study to develop an imaging analysis algorithm for the eyestar 900 to identify keratoconus corneas and improve biometry for intraocular lens calculations

keratoconus is a progressive corneal ectatic disorder, characterised by thinning, protrusion and irregularity. corneal imaging is crucial in keratoconus detection and progression analysis. detection of keratoconus in early stages is important and has therapeutic consequence, whether to plan a surgical intervention or calculating an intraocular lens, before cataract surgery, as standard lens calculation techniques may lead to wrong results in patients with a keratoconus. the eyestar 900 is a swept-source oct biometer and has the potential to be used for early keratoconus identification and progression analysis.

Eligibility criteria:
inclusion criteria: 1. patients with all stages of keratoconus 2. patients with healthy corneas exclusion criteria: 1. keratoconus patients with hydrops, status following hydrops 2. patients with degenerative corneal diseases 3. patients after corneal surgery

Keywords: keratoconus eye diseases cataract corneal imaging corneal topography corneal tomography corneal ectasia
bioequivalence study between "da-5215 tab" and "da-5215-r tab"

Conditions: Healthy

Summary: an open-label, randomized, fasting condition, single-dose, cross-over study to evaluate the bioequivalence between "da-5215 tab" and "da-5215-r tab" in healthy volunteers

1. study design: an open-label, randomized, 2-sequence, 2-period, fasting condition, single-dose, per oral, cross-over study 2. administration method: the subject should maintain a minimum of 10 hours of fasting status before administration, and give an oral dose of 1 tablet (da-5215 or da-5215-r) with 150 ml of water at around 8 a.m. on 1d of each period. the subject should not chew or break the drug, but should swallow in whole with water. the difference in administration time between the subjects is about one minute apart, considering the blood collection time. 3. wash out period: at least 7 days 4. blood collection time: before the administration,15, 30, 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48 hours after the administration (total 16 times)

Eligibility criteria:
inclusion criteria: 1. a person who aged 19 or older at the time of screening 2. bmi of 18 to 30 (bmi calculation: kg/m2) - males weighing 50kg or more, females weighing 45kg or more 3. no congenital or chronic diseases or pathological symptoms 4. a person who is judged to be suitable for the study by the investigator based on the clinical laboratory examination 5. a person who agreed to use contraception from the first administration of ip to a week after the last administration of ip 6. a person who has fully understood the contents of the consent form for the study and signed the consent form voluntarily and recorded the date of signature exclusion criteria: 1. a person who has taken a drug that significantly induces (e.g., barbital) or inhibits the drug metabolic enzyme within 30 days prior to the first administration of ip 2. a person who has participated in other clinical trials within six months prior to the first administration of the ip 3. a person who has had whole blood transfusion within 8 weeks or the apheresis within 2 weeks before the first administration of ip 4. a person who has medical history of gastric resection that can affect the drug absorption 5. a person with a history of regular alcohol intake within a month prior to the first administration of the ip: * male: more than 21 cups/week * female: more than 14 cups/week (1 cup: 50 ml of soju, 250 ml of beer, 30ml of spirits) 6. a person who is hypersensitive to any of the ip components 7. a person who has medical history of mental disease 8. a person who is judged not to be suitable for the study by the investigator 9. lactating or possibly pregnant women